Customer Success Stories

Omnify Empower PLM has been recognized by G2 Crowd, the world's leading business software review platform, as a high performer
earning the highest overall satisfaction score in the PLM Software Grid Report.

The team at Axonics had previous experience with Product Lifecycle Management (PLM) at another medical device start-up.
They knew the benefits that an electronic, online PLM solution could provide a small to medium-sized medical device company.

One particular area where Axonics saw the greatest benefit of a PLM solution was with electronic sign-offs.
With paper-based processes and insufficient signatories, approvals are serial in nature and the absence of a key approver can translate into a major delay.
Axonics wanted to prevent this issue with an automated system that offered the ability for Axonics staff to continue the approval process for documents/drawings/training/etc., on or off-site, via remote logins and allow for the assignment of signatories.

Axonics wanted a software solution that would facilitate Active Implantable Medical Device (AIMD) product development under a Quality System compliant to ISO 13485 and the FDA CFR (Code of Federal Regulations), as well as other regulatory frameworks.

"We were told by industry experts that a new Sacral Neuromodulation product would take five years to receive CE marking, but we accomplished that milestone in just two years after initiating design controls with Omnify Empower.
Omnify facilitates rapid design, document, and BOM controls in tandem with supplier approvals and vendor item linkages.
All these aspects and more allow us to achieve our ambitious timelines."

As a small developer and manufacturer of a complex robotic prosthetic device, maintaining a paper-based document control and change control system was becoming unmanageable.
The complexity of the device meant that even a small change to the product or documentation resulted in a large paper documentation package which had to be manually compiled and routed for review and approval.

With a major re-design project on the immediate horizon, it was essential to identify and implement a more efficient document control solution ahead of the large volume of new product design documentation that was expected.
BionX wanted an electronic system that would be able to efficiently manage a multi-level product structure/Bill of Material (BOM) and engineering change orders with the ability to expand into other electronic records management such as Training Records, CAPA/Quality issues and supplier management.
The system also had to meet the FDA 21 CFR Part 11 compliance requirements for electronic records and electronic signatures.

"We went through a discovery process over the course of several months, evaluating about five different solutions," stated Rick Smith, Sr. Director, Quality & Regulatory for BionX Medical Technologies.
"A matrix of requirements was created and the different solutions were ranked as to how well they solved our particular needs and Omnify Empower PLM was our top choice."

Key benefits:

Time to market: Launched a completely overhauled product iteration from concept to sales in 15 months and on schedule

Coghlin Companies, together with its wholly-owned subsidiaries Columbia Tech and Cogmedix, collectively provide Concept to Commercialization services to a diversified group of capital equipment manufacturers, device manufacturers, and select entrepreneurs throughout the United States.

As part of a corporate initiative, Columbia Tech and Cogmedix were both investing in new systems to help the companies grow, enhance consistency, and improve quality and traceability. This included upgrading their Epicor Enterprise Resource Planning (ERP) system and adopting Manufacturing Execution System (MES) and Product Lifecycle Management (PLM) systems. PLM was part of this endeavor in order to address concerns with their document control and engineering change release process.

"We found that Omnify Software offered superior value, flexibility, scalability, and ease of use compared to alternatives we reviewed,” stated Tessa Kalarickal, Director of Business Systems. “It is also a proven leader in PLM for the mid-size market as it was already deployed in multiple key accounts within the Coghlin Companies and already integrated with Epicor at some of these accounts."

Key benefits:

Time-savings: Automated and integrated systems eliminate the need to re-enter data in multiple systems. Everyone on the productteam/project management has visibility into product information to save time searching for information.

Efficiency: Better traceability of changes and the ability to accurately measure processing and review times. The level of compliance and control of documentation is exponentially better than the previous system.

Centralized and Automated Development Processes Get Accolades from ISO Auditor

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Cytonome develops, manufactures and markets the most advanced, highest quality cell purification systems available worldwide for BioMedicine, BioIndustry, and BioScience.

They have an innovative focus to developing new products, where engineering develops concepts in parallel with manufacturing during the prototype phase.
More efficient communication between these departments was the drive to adopt a PLM system.
The company was managing product development with tools that did not communicate with each other.
Information had to be manually entered into separate systems which took up valuable employee time, introduced costly human data entry errors and resulted in systems containing incorrect or out-of-date information.

Cytonome was also preparing for their International Organization for Standardization (ISO) certification and needed to have formal processes in place to demonstrate proper management, tracking and reporting of product development and manufacturing procedures and information.

"Our overall product development processes are faster and more efficient due to the time savings and improved data accuracy we have realized by implementing Omnify Empower as our central product information management system," stated Heather Kiessling, Chief Financial Officer for Cytonome.
"The most significant business benefit of using Omnify Empower is the real time global updates among engineering, purchasing and manufacturing that we did not have before."

Key Benefits:

First ISO audit resulted in zero findings and accolades from auditor

Achieved goal of real time information sharing among engineering, purchasing and manufacturing

Leader in Innovative Technologies for the Cardiac and Vascular Markets Automates Engineering Change and Training Processes for Continuous Improvement and FDA/ISO Compliance

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RenalGuard Solutions (formerly PLC Medical) was managing product data with a homegrown system developed in an Access database that required a great deal of manual intervention and paper processes.
If someone changed a Quality document they would have to print it out, pull out the old document from a folder, put in the new version and then walk around from person to person for sign-off.
This setup did not have the necessary tracking for who was actually trained on a certain procedure, who signed off on an Engineering Change Order (ECO), or when items were signed-off.
In addition, it did not allow them to capture employee product knowledge so if anyone left the company they took that knowledge with them.

The company was looking to replace the homegrown database with a solution that would allow Documentation Control to keep ECOs moving through an automated system rather than a "walking system" where they had to physically walk from person to person for sign-off.
In addition, being in a highly regulated industry required PLC to set up more formal, automated processes.

Seahorse Bioscience was managing product development with paper-based processes.
Information such as part numbers and Engineering Change Orders (ECOs) were processed using Excel spreadsheets.
This eventually became inefficient, risky and laborious.
In addition, the company had two corporate divisions.
With the data spillover that can result from any collaborative work between multiple corporate divisions, a Product Lifecycle Management (PLM) system became a necessity in order to centralize and control information.

The company's primary goal was to find a means to centralize and automate their document control tasks.
They wanted to have one corporate source for part number generation, ECO generation and tracking, and a secure corporate repository for design/product data with automated revision control.

The Thermage solution from Solta Medical is a Class II medical device and therefore is required to meet stringent Food and Drug Administration (FDA) compliance requirements.
Solta Medical must have a proper document structure in place to show the history of how a product was built, with signed and dated documents.

Solta Medical wanted a central and secure location for all Thermage product data to be vaulted so that they could easily track, manage and find information.
They also wanted to implement a system that would support better compliance and manufacturing processes.